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Sponsored by: |
Jikei University School of Medicine Hospital |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00664456 |
RATIONALE: Androgens can cause the growth of prostate cancer cells. Luteinizing hormone-releasing hormone agonists may lessen the amount of androgens made by the body. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving luteinizing hormone-releasing hormone agonist together with an iodine I 125 implant may be an effective treatment for patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying how well giving luteinizing hormone-releasing hormone agonist therapy together with an iodine I 125 implant works with or without additional luteinizing hormone-releasing hormone agonist therapy in treating patients with previously untreated prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: iodine I 125 Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: releasing hormone agonist therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III, Multicenter, Randomized, Controlled Study of Neoadjuvant LHRH-Agonist Therapy and Permanent I-125 Implantation With vs. Without Adjuvant LHRH-Agonist Therapy in Patients With Untreated Intermediate-Risk Prostate Cancer. |
Estimated Enrollment: | 420 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed prostate cancer
Intermediate-risk disease, as defined by the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Japan | |
Jikei University School of Medicine Hospital | Recruiting |
Tokyo, Japan, 125-8506 | |
Contact: Shin Egawa, MD, PhD 81-3-3437-2370 |
Principal Investigator: | Shin Egawa, MD, PhD | Jikei University School of Medicine Hospital |
Study ID Numbers: | CDR0000593653, JUSMH-BRI-GU05-01 |
Study First Received: | April 22, 2008 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00664456 |
Health Authority: | Unspecified |
stage II prostate cancer stage I prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Iodine |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Anti-Infective Agents Anti-Infective Agents, Local Neoplasms Neoplasms by Site Growth Substances |
Therapeutic Uses Physiological Effects of Drugs Trace Elements Micronutrients Pharmacologic Actions |